None listed
Conditions
Interventions
Dietary Supplement : -MH-Pro Low-Dose Group: Oral intake of 2 sachets, once daily
(L, rhamnosus CBT-LR5 1?10^10 CFU/day+skim milk 1,622 mg/day)
-MH-Pro High-Dose Group: Oral intake of 2 sachets, once
Sponsors
Cell Biotech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 60 or older who complain of memory decline at the time of the screening test 2) Individuals whose CERAD-K word list memory/recall/recognition test scores show a 1-1.5 SD decrease from the normal range (satisfying at least one of the three items) 3) Individuals with a total score of 22 or lower on the Korean version of the Montreal Cognitive Assessment (MOCA-K) 4) Individuals who have fully understood the detailed explanation of this human study, voluntarily decided to participate, and provided written consent to comply with the guidelines
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for major depressive disorder or who have been treated within the last 3 years, or those with a score of 16 or higher on the Beck Depression Inventory-II (BDI-II) 2) Individuals with diseases accompanied by cognitive decline symptoms, such as dementia, Parkinson's disease, or stroke 3) Individuals who have consistently consumed probiotic supplements (or probiotic products) and fermented dairy products (yogurt, cheese, etc.) four or more times per week within the 4 weeks prior to the screening test 4) Individuals with a history of alcohol abuse or dependence within the 3 months prior to the screening test 5) Individuals unable to comprehend written Korean 6) Individuals with clinically significant acute or chronic cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal, urinary, neuropsychiatric, musculoskeletal, inflammatory, hematologic/oncologic, or gastrointestinal diseases requiring treatment 7) Individuals who have taken medications, health supplements, or herbal medicine related to cognitive function and memory improvement within the 1 month prior to the screening test (see prohibited medications) 8) Individuals who have taken psychotropic medications such as antipsychotics, antidepressants, mood stabilizers, sleeping pills, or anxiolytics within the 1 month prior to the screening test 9) Individuals who have taken antibiotics within the 4 weeks prior to the screening test 10) Individuals who have donated whole blood within the 1 month prior to the screening test or have donated blood components within 2 weeks 11) Individuals who have participated in other human studies within the 3 months prior to the screening test 12) Individuals with the following diagnostic test results: ?AST, ALT > 3 times the upper limit of the reference range ?Serum Creatinine > 2.0 mg/dL 13) Individuals deemed unsuitable for study participation by the principal investigator based on diagnostic test results or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog13 | — |
Secondary
| Measure | Time frame |
|---|---|
| MOCA-K;Amyloid-ß, BDNF, Tau protein, AchE, PGE2, MCP-1;Changes in gut microbiota composition | — |
Countries
Korea, Republic of
Contacts
Public ContactEun-Soo Jung
Jeonbuk National University Hospital
Outcome results
None listed